~92 spots leftby Dec 2026

Combined Therapies for Recurrent Brain Cancer

Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Monteris Medical
Must not be taking: Bevacizumab
Disqualifiers: More than 3 lesions, Concurrent malignancies, Serious infection, others
No Placebo Group
Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used bevacizumab within 4 weeks of starting the study. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of this treatment for recurrent brain cancer?

Research shows that radiotherapy, including stereotactic radiosurgery and reirradiation, can improve survival and quality of life for patients with recurrent brain metastases, with minimal side effects. These treatments are effective in controlling local brain disease and are considered safe options for managing relapsing brain conditions.12345

Is the combined therapy for recurrent brain cancer generally safe for humans?

Image-guided radiation therapy (IGRT) and intensity-modulated radiotherapy (IMRT) are generally considered safe, with some risk of side effects like gastrointestinal and genitourinary issues. The safety of these therapies has been a focus of research, and they are commonly used in clinical practice.36789

How is the treatment of radiation therapy unique for recurrent brain cancer?

Radiation therapy for recurrent brain cancer is unique because it uses advanced techniques like stereotactic radiotherapy (SRT) and intensity-modulated radiation therapy (IMRT) to precisely target tumors, minimizing damage to healthy brain tissue. This approach allows for a second course of radiation, which is not standard, offering a potential option for patients with recurrent tumors.310111213

Research Team

Eligibility Criteria

This trial is for adults over 18 who've had brain metastases treated with SRS at least 3 months ago. They must be stable on low-dose steroids, able to undergo biopsy and laser therapy, and commit to the study's follow-up. Women of childbearing age need a negative pregnancy test and agree to use contraception.

Inclusion Criteria

I am 18 years old or older.
I've been stable for 3 days on a low steroid dose.
I had my initial SRS treatment for the target lesion over 3 months ago.
See 10 more

Exclusion Criteria

My cancer outside the brain is quickly getting worse.
I do not have any serious infections or other major health issues.
Patients unable to comply with study requirements
See 9 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or hypofractionated radiation therapy (RT) for recurrent brain metastases

3 months
Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

24 months
Post-op visit, 1 month visit, and subsequent follow-up visits until study exit or 24 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

  • Laser Interstitial Thermal Therapy (Procedure)
  • Radiation Therapy (Radiation)
  • Steroid Therapy (Corticosteroid)
Trial OverviewThe REMASTer trial compares two treatment strategies after initial SRS for brain metastases: Radiation Therapy versus Laser Interstitial Thermal Therapy combined with Steroid Therapy. It's randomized, meaning patients are put into groups by chance.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Recurrent TumorExperimental Treatment2 Interventions
Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).
Group II: Radiation NecrosisExperimental Treatment2 Interventions
Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.

Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

🇨🇦
Approved in Canada as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇯🇵
Approved in Japan as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇳
Approved in China as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇭
Approved in Switzerland as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Kettering HealthKettering, OH
Cleveland ClinicCleveland, OH
UCLALos Angeles, CA
Medical College of WisconsinMilwaukee, WI
More Trial Locations
Loading ...

Who Is Running the Clinical Trial?

Monteris Medical

Lead Sponsor

Trials
10
Patients Recruited
1,600+

Findings from Research

Radiotherapy and chemotherapy of brain metastases.Soffietti, R., Costanza, A., Laguzzi, E., et al.[2018]
Stereotactic radiosurgery is a commonly used and effective treatment for recurrent or progressive brain metastases, showing good results in local brain control and patient survival based on various clinical studies.
This treatment is considered relatively safe, with a low incidence of brain toxicity side effects, but further well-designed randomized studies are needed to refine patient selection and treatment guidelines.
Salvage stereotactic radiosurgery for brain metastases.Klironomos, G., Bernstein, M.[2013]
Feasibility of Salvage Re-irradiation With Stereotactic Radiotherapy for Recurrent Glioma Using CyberKnife.Adachi, K., Hayashi, K., Kagawa, N., et al.[2019]
Improving radiotherapy for brain tumors.Woo, SY., Maor, MH.[2005]
Reirradiation for patients with brain metastases can effectively alleviate symptoms and improve survival rates, with minimal late neurotoxicity, making it a valuable treatment option that is often underutilized.
Recent studies indicate that stereotactic radiosurgery, in addition to traditional whole brain radiotherapy, offers promising results for reirradiation, enhancing treatment options for patients with recurrent brain metastases.
Reirradiation for progressive brain metastases.Bahl, A., Kumar, M., Sharma, DN., et al.[2022]
Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update.Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]
Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy.Tomita, N., Uchiyama, K., Mizuno, T., et al.[2021]
The phase II trial aims to evaluate the safety and feasibility of combining regional hyperthermia with moderately dose-escalated salvage radiotherapy for recurrent prostate cancer, focusing on minimizing severe adverse events.
If proven safe and feasible, this study could lead to a larger phase III trial to determine if adding hyperthermia improves treatment outcomes, specifically biochemical control of the cancer.
Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer. Protocol of a phase II trial.Müller, AC., Zips, D., Heinrich, V., et al.[2021]
A Novel Salvage Option for Local Failure in Prostate Cancer, Reirradiation Using External Beam or Stereotactic Radiation Therapy: Systematic Review and Meta-Analysis.Corkum, MT., Mendez, LC., Chin, J., et al.[2022]
Despite aggressive treatments for brain tumors, recurrence remains common, and there is currently no standard care for managing recurrent tumors, making treatment challenging.
Advancements in radiation therapy techniques, such as IMRT and SRS, have improved tumor targeting and reduced damage to healthy brain tissue, but the benefits and risks of reirradiation for recurrent tumors are still debated, particularly regarding survival and toxicity.
The evolving role of reirradiation in the management of recurrent brain tumors.De Pietro, R., Zaccaro, L., Marampon, F., et al.[2023]
In a study of 33 patients with recurrent brain metastases treated with salvage stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSRT), local progression occurred in only 9.8% of brain metastases, indicating effective local control.
After 2 years, 37.7% of patients were alive, and 72% were free from distant brain failure, with no increase in toxicity or neurologically related deaths, suggesting that focal radiotherapy is a safe and effective option for managing limited brain metastases.
Repeated stereotactic radiosurgery for recurrent brain metastases: An effective strategy to control intracranial oligometastatic disease.Jablonska, PA., Serrano Tejero, D., Calvo González, A., et al.[2020]
CyberKnife stereotactic radiotherapy (SRT) was found to be an effective treatment for recurrent glial tumors, with a median survival time of 22.3 months after recurrence among 37 patients studied over a follow-up period of up to 57 months.
The treatment showed no significant toxicity, indicating that SRT is a safe option, especially for high-grade tumors, which had a median survival of 29 months compared to 19 months for low-grade tumors.
Efficacy of stereotactic radiotherapy as salvage treatment for recurrent malignant gliomas.Ekici, K., Ozseker, N., Mayadagli, A., et al.[2018]
Salvage Radiation Therapy for Patients With Relapsing Glioblastoma Multiforme and the Role of Slow Fractionation.Ciernik, IF., Gager, Y., Renner, C., et al.[2022]

References

Radiotherapy and chemotherapy of brain metastases. [2018]
Salvage stereotactic radiosurgery for brain metastases. [2013]
Feasibility of Salvage Re-irradiation With Stereotactic Radiotherapy for Recurrent Glioma Using CyberKnife. [2019]
Improving radiotherapy for brain tumors. [2005]
Reirradiation for progressive brain metastases. [2022]
Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]
Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]
Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer. Protocol of a phase II trial. [2021]
A Novel Salvage Option for Local Failure in Prostate Cancer, Reirradiation Using External Beam or Stereotactic Radiation Therapy: Systematic Review and Meta-Analysis. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The evolving role of reirradiation in the management of recurrent brain tumors. [2023]
Repeated stereotactic radiosurgery for recurrent brain metastases: An effective strategy to control intracranial oligometastatic disease. [2020]
Efficacy of stereotactic radiotherapy as salvage treatment for recurrent malignant gliomas. [2018]
Salvage Radiation Therapy for Patients With Relapsing Glioblastoma Multiforme and the Role of Slow Fractionation. [2022]